Job Title: Senior Engineer, Compliance
Reports To: Senior Manager, Electronics Engineering
Department：LBS CH Shanghai R&D
Purpose/Objective:
- The Senior Engineer, Compliance will be responsible to ensure the company to comply with all applicable safety standards and regulations (CCC, CSA/UL/TUV and RoHS, etc.) and to ensure Risk Analysis, Risk management for Leica products. To ensure quality and on time delivery of our products that meet those standards and regulations to the customers.
Area of Responsibilities:
- Execute Risk analysis for Leica products.
- Monitor regulation, directive and standards update, execute impact analysis and generate action.
- Generate or update product compliance related processes, templates.
- Product compliance design input and review in design changes and NPD projects.
- Execute independently product EMC test in 3rd-party lab following relevant IEC/EN/ISO/FCC standards.
- Execute independently product Safety test in 3rd-party lab following relevant IEC/EN/ISO/CSA standards.
- Execute independently product transportation/Environment test in 3rd-party lab following relevant IEC/EN/ISO/ISTA standards.
- Ensure independently ROHS/REACH compliance for parts/components.
- Develop Compliance test plan based on NPD and DCR schedule.
- Develop ROHS/REACH validation plan for different products.
Person Specification：
Skills / Competencies
- Expertise in risk management in accordance with ISO 14971.
- Strong understanding of applicable standards and the ability to translate regulatory and standards requirements into practical processes and actions.
- Understanding on ISO/IEC/EMC/ISTA standard e.g. IEC61010, IEC61326, ISTA 2B/3A, CSA61010, FCC Part15.
- Good knowledge of EE and ME, especially on EE field(e.g. digital, analog, PCB layout, terminals, motor control, heating).
- Able to define different test specifications for different products according to compliance standards.
- Able to work on EMC testing setup, testing following EMC standards.
- Able to work on safety testing setup, testing following product safety standards.
- Able to work on transportation/environment testing setup, testing following IEC/ISO/ISTA/EN standards.
- Ability to work on multiple tasks.
- Good priority skill & result driving.
- Deep understanding on ISO, EMC/Safety standard.
- Global collaboration experience within CFT.
Functional knowledge
- Demonstrates and applies expanded conceptual knowledge in own discipline and with an understanding of related disciplines.
Business expertise
- Uses understanding of key business drivers to prioritize accomplish own work.
Leadership
- No supervisory responsibilities but provides informal guidance to new team members.
Problem solving
- Solves problems in straightforward situations with coaching; analyses possible solutions using technical experience and judgment and precedents.
Impact
- Impacts quality of own work and the work of others on the team; works within guidelines and policies.
Interpersonal Skills
- Explains complex information to others in straightforward situations.
Education
- B.S. degree or above in mechanical/electrical engineering or related.
Experience
- Minimal 5 years industry experience in electronics design, testing and manufacturing,;
- Minimial 2 years’ experience on product risk analysis.
- Medical device or life science product development experience.
Language
- Native Chinese & Good English.
Position
Senior Engineer, Compliance
Department
LBS CH Shanghai R&D
Reports to
Senior Manager, Electronics Engineering
Writer
Auditor
Approved by
Revision
00
Effective Date
职位名称：资深合规工程师
汇报对象：资深电子工程经理
部门：LBS核心病理上海研发中心
- 目的/目标：
高级合规工程师负责确保公司遵守所有适用的安全标准和法规要求（如CCC、CSA/UL/TUV、RoHS等），并负责徕卡产品的风险分析与风险管理工作；在满足上述标准和法规的前提下，确保产品质量并按时交付给客户。
。
职责范围：
• 负责开展徕卡产品的风险分析工作。
• 跟踪法规、指令及标准的更新，开展影响分析并制定相应行动措施。
• 制定或更新与产品合规相关的流程及模板。
• 在设计变更及新产品开发（NPD）项目中，提供产品合规方面的设计输入并开展评审。
• 独立执行第三方实验室的产品EMC测试（依据IEC/EN/ISO/FCC标准）。
• 独立执行第三方实验室的产品安全测试（依据IEC/EN/ISO/CSA标准）。
• 独立执行第三方实验室的产品运输/环境测试（依据IEC/EN/ISO/ISTA标准）。
• 独立确保零部件/组件符合RoHS/REACH要求。
• 根据新产品开发（NPD）和设计变更请求（DCR）计划制定合规性测试方案。
• 针对不同产品制定RoHS/REACH验证计划。
任职要求：
技能/能力
• 精通依据 ISO 14971 开展风险管理。
• 熟悉ISO/IEC/EMC/ISTA标准（如IEC61010、IEC61326、ISTA 2B/3A、CSA61010、FCC Part15）。
• 扎实的电气和机械工程知识（侧重电气领域：数字/模拟电路、PCB布局、端子、电机控制、加热系统）。
• 能够根据合规标准为不同产品制定测试规范。
• 能够搭建EMC测试环境并执行标准测试。
• 能够搭建安全测试环境并执行标准测试。
• 能够搭建运输/环境测试环境并执行标准测试。
• 具备多任务处理能力。
专业知识
• 在本专业领域展现并应用扩展的概念性知识，理解相关学科内容 业务专长
• 运用对关键业务驱动因素的理解来优先完成本职工作 领导力
• 无管理职责，但能为新团队成员提供非正式指导 问题解决
• 在指导下解决常规问题，能运用技术经验、判断力和先例分析可能的解决方案 影响
• 影响自身及团队工作质量，在准则和政策框架内开展工作 人际交往能力
• 能够向他人清晰解释复杂信息 教育背景
• 机械/电气工程或相关专业本科及以上学历 工作经验
• 至少5年电子设计、测试和制造行业经验
- 至少2年产品风险管理经验
• 有医疗器械或生命科学产品开发经验者优先
语言能力
• 中文母语，良好的英语能力
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Skills Required
- B.S. degree in mechanical/electrical engineering or related
- 5 years industry experience in electronics design, testing and manufacturing
- 2 years experience in product risk analysis
- Medical device or life science product development experience
- Strong understanding of ISO/IEC/EMC/ISTA standards
- Expertise in risk management
Cepheid Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cepheid and has not been reviewed or approved by Cepheid.
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Leave & Time Off Breadth — PTO and paid holidays are portrayed as robust, with formal programs and mentions of generous time off and rollover in some cases. This breadth supports a positive view of time-off availability.
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Healthcare Strength — Core medical, dental, and vision coverage is highlighted repeatedly and is viewed as comprehensive for regular full‑time employees. Descriptions such as “good” or “great” benefits reinforce the strength of the health coverage.
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Retirement Support — A 401(k) plan with company matching is consistently included as part of the package. The presence of matching contributions strengthens perceived retirement readiness.
Cepheid Insights
What We Do
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.
